Changing Tactics? Optimizing ECT in Difficult-to-treat Depression

NCT05923801 | Recruiting DMC

• 1 other identifier: S67329
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomized controlled trial is to address which treatment strategy (continue right unilateral (RUL) ECT or switch to bitemporal (BT) ECT speeds up recovery and has the least impact on memory function, in case of early non-response during an acute course of ECT for difficult-to-treat depression. The main questions it aims to answer are:

• Assess the antidepressant efficacy and cognitive impact of the continuation of an ongoing treatment with RUL ECT compared to switching the treatment technique to BT ECT, in patients failing to show an early response to an acute course of ECT for major depression;
• Assess group and subject-specific trajectories of depressive symptom severity and neurocognitive performance during the acute ECT course and up to 3 months post-treatment. Participants treated with ECT for depression, showing no 'response' (≥50 percent decrease in depressive symptom severity compared to baseline) after 4 treatment sessions, will be randomized to either switch to BT ECT or continue with RUL ECT. Mood and neurocognitive assessments will be performed at baseline, after 4 ECT sessions (before randomization), after 8 ECT sessions, at the end of the acute course and 3 month after the acute course.

Conditions

Depression

Keywords

Electroconvulsive Therapy; Depression; Cognition

Outcome Measures

Primary Outcomes (8)

• Change form baseline Depressive Symptom Severity

  mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)

  after 4 ECT sessions (2 weeks)

• Change form baseline Depressive Symptom Severity

  mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)

  after 8 ECT sessions (4 weeks)

• Depressive Symptom Severity

  mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)

  at the end of acute ECT course (up to 7 weeks)

• Depressive Symptom Severity

  mean scores on the Inventory of Depressive Symptomatology-Clinician Rated (IDS-CR)

  3 months post-acute course

• Autobiographical Memory

  Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)

  after 4 ECT sessions (2 weeks)

• Autobiographical Memory

  Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)

  after 8 ECT sessions (4 weeks)

• Autobiographical Memory

  Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)

  at the end of acute ECT course (up to 7 weeks)

• Autobiographical Memory

  Mean scores on the Colombia University Autobiographical Memory Interview Short Form (CU-AMI-SF)

  3 months post-acute course

Secondary Outcomes (6)

• Response/remission status

  at the end of acute ECT course (up to 7 weeks)

• number of ECT treatments needed to achieve response/remission

  at the end of acute ECT course (up to 7 weeks)

• Neurocognitive performance (RAVLT)

  after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course

• Neurocognitive performance (MoCA)

  after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course

• Neurocognitive performance (COWAT)

  after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course

Other Outcomes (2)

• Clinical characteristics (CORE)

  after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course

• Clinical characteristics (PDAS)

  after 4 ECT sessions (2 weeks), after 8 ECT sessions (4 weeks), at the end of acute ECT course (up to 7 weeks), 3 months post-acute course

Study Arms (2)

BT ECT

ACTIVE COMPARATOR

Participants showing no response will be switched to BT ECT until remission is achieved.

Device: switch to BT electrode position

RUL ECT

ACTIVE COMPARATOR

Participants showing no response will continue with RUL ECT until remission is achieved.

Device: continue with RUL electrode position

Interventions

switch to BT electrode position DEVICE

use of different electrode positions of ECT device

BT ECT

continue with RUL electrode position DEVICE

use of different electrode positions of ECT device

RUL ECT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Voluntary written informed consent of the participant or their legally authorized representative has been obtained prior to any screening procedures
• Age 18 or older
• Diagnosis of major depressive disorder (DSM-5 296.21-30) or bipolar disorder, depressed (DSM-5 296.51-54; 296.84), confirmed by MINI (Mini International Neuropsychiatric Interview)

You may not qualify if:

• Contra-indication for general anesthesia
• Non-Dutch speaking
• Diagnosis of schizoaffective disorder or schizophrenia, confirmed by MINI
• Diagnosis of substance use disorder in the past six months, confirmed by MINI
• Diagnosis of neurocognitive disorder or intellectual disability alongside a MoCA score \<23
• Previous ECT course in the past three months
• Participation in an interventional Trial with an investigational medicinal product or device
• Pregnancy

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• Universiteit Antwerpen: collaborator
• AZ Sint-Jan AV: collaborator
• General Hospital Groeninge: collaborator

Study Sites (1)

UPC Kortenberg

Kortenberg, Belgium

RECRUITING

Related Publications (17)

• Kolshus E, Jelovac A, McLoughlin DM. Bitemporal v. high-dose right unilateral electroconvulsive therapy for depression: a systematic review and meta-analysis of randomized controlled trials. Psychol Med. 2017 Feb;47(3):518-530. doi: 10.1017/S0033291716002737. Epub 2016 Oct 26.

  PMID: 27780482 BACKGROUND

• Semkovska M, Landau S, Dunne R, Kolshus E, Kavanagh A, Jelovac A, Noone M, Carton M, Lambe S, McHugh C, McLoughlin DM. Bitemporal Versus High-Dose Unilateral Twice-Weekly Electroconvulsive Therapy for Depression (EFFECT-Dep): A Pragmatic, Randomized, Non-Inferiority Trial. Am J Psychiatry. 2016 Apr 1;173(4):408-17. doi: 10.1176/appi.ajp.2015.15030372. Epub 2016 Feb 19.

  PMID: 26892939 BACKGROUND

• Kellner CH, Knapp R, Husain MM, Rasmussen K, Sampson S, Cullum M, McClintock SM, Tobias KG, Martino C, Mueller M, Bailine SH, Fink M, Petrides G. Bifrontal, bitemporal and right unilateral electrode placement in ECT: randomised trial. Br J Psychiatry. 2010 Mar;196(3):226-34. doi: 10.1192/bjp.bp.109.066183.

  PMID: 20194546 BACKGROUND

• Sackeim HA, Prudic J, Devanand DP, Nobler MS, Haskett RF, Mulsant BH, Rosenquist PB, McCall WV. The benefits and costs of changing treatment technique in electroconvulsive therapy due to insufficient improvement of a major depressive episode. Brain Stimul. 2020 Sep-Oct;13(5):1284-1295. doi: 10.1016/j.brs.2020.06.016. Epub 2020 Jun 22.

  PMID: 32585354 BACKGROUND

• Lapidus KA, Kellner CH. When to switch from unilateral to bilateral electroconvulsive therapy. J ECT. 2011 Sep;27(3):244-6. doi: 10.1097/YCT.0b013e31820059e1. No abstract available.

  PMID: 21681108 BACKGROUND

• Birkenhager TK, Roos J, Kamperman AM. Improvement after two sessions of electroconvulsive therapy predicts final remission in in-patients with major depression. Acta Psychiatr Scand. 2019 Sep;140(3):189-195. doi: 10.1111/acps.13054. Epub 2019 Jun 7.

  PMID: 31104321 BACKGROUND

• Rush AJ, Gullion CM, Basco MR, Jarrett RB, Trivedi MH. The Inventory of Depressive Symptomatology (IDS): psychometric properties. Psychol Med. 1996 May;26(3):477-86. doi: 10.1017/s0033291700035558.

  PMID: 8733206 BACKGROUND

• van Diermen L, van den Ameele S, Kamperman AM, Sabbe BCG, Vermeulen T, Schrijvers D, Birkenhager TK. Prediction of electroconvulsive therapy response and remission in major depression: meta-analysis. Br J Psychiatry. 2018 Feb;212(2):71-80. doi: 10.1192/bjp.2017.28.

  PMID: 29436330 BACKGROUND

• Rush AJ, Trivedi MH, Wisniewski SR, Nierenberg AA, Stewart JW, Warden D, Niederehe G, Thase ME, Lavori PW, Lebowitz BD, McGrath PJ, Rosenbaum JF, Sackeim HA, Kupfer DJ, Luther J, Fava M. Acute and longer-term outcomes in depressed outpatients requiring one or several treatment steps: a STAR*D report. Am J Psychiatry. 2006 Nov;163(11):1905-17. doi: 10.1176/ajp.2006.163.11.1905.

  PMID: 17074942 BACKGROUND

• Kirov G, Jauhar S, Sienaert P, Kellner CH, McLoughlin DM. Electroconvulsive therapy for depression: 80 years of progress. Br J Psychiatry. 2021 Nov;219(5):594-597. doi: 10.1192/bjp.2021.37.

  PMID: 35048827 BACKGROUND

• Kellner CH, Obbels J, Sienaert P. When to consider electroconvulsive therapy (ECT). Acta Psychiatr Scand. 2020 Apr;141(4):304-315. doi: 10.1111/acps.13134. Epub 2019 Dec 23.

  PMID: 31774547 BACKGROUND

• Kellner CH, Knapp RG, Petrides G, Rummans TA, Husain MM, Rasmussen K, Mueller M, Bernstein HJ, O'Connor K, Smith G, Biggs M, Bailine SH, Malur C, Yim E, McClintock S, Sampson S, Fink M. Continuation electroconvulsive therapy vs pharmacotherapy for relapse prevention in major depression: a multisite study from the Consortium for Research in Electroconvulsive Therapy (CORE). Arch Gen Psychiatry. 2006 Dec;63(12):1337-44. doi: 10.1001/archpsyc.63.12.1337.

  PMID: 17146008 BACKGROUND

• Kellner CH, Husain MM, Knapp RG, McCall WV, Petrides G, Rudorfer MV, Young RC, Sampson S, McClintock SM, Mueller M, Prudic J, Greenberg RM, Weiner RD, Bailine SH, Rosenquist PB, Raza A, Kaliora S, Latoussakis V, Tobias KG, Briggs MC, Liebman LS, Geduldig ET, Teklehaimanot AA, Lisanby SH; CORE/PRIDE Work Group. Right Unilateral Ultrabrief Pulse ECT in Geriatric Depression: Phase 1 of the PRIDE Study. Am J Psychiatry. 2016 Nov 1;173(11):1101-1109. doi: 10.1176/appi.ajp.2016.15081101. Epub 2016 Jul 15.

  PMID: 27418379 BACKGROUND

• Semkovska M, McLoughlin DM. Objective cognitive performance associated with electroconvulsive therapy for depression: a systematic review and meta-analysis. Biol Psychiatry. 2010 Sep 15;68(6):568-77. doi: 10.1016/j.biopsych.2010.06.009. Epub 2010 Jul 31.

  PMID: 20673880 BACKGROUND

• Sackeim HA, Decina P, Kanzler M, Kerr B, Malitz S. Effects of electrode placement on the efficacy of titrated, low-dose ECT. Am J Psychiatry. 1987 Nov;144(11):1449-55. doi: 10.1176/ajp.144.11.1449.

  PMID: 3314538 BACKGROUND

• Husain MM, Rush AJ, Fink M, Knapp R, Petrides G, Rummans T, Biggs MM, O'Connor K, Rasmussen K, Litle M, Zhao W, Bernstein HJ, Smith G, Mueller M, McClintock SM, Bailine SH, Kellner CH. Speed of response and remission in major depressive disorder with acute electroconvulsive therapy (ECT): a Consortium for Research in ECT (CORE) report. J Clin Psychiatry. 2004 Apr;65(4):485-91. doi: 10.4088/jcp.v65n0406.

  PMID: 15119910 BACKGROUND

• Martinez-Amoros E, Goldberg X, Galvez V, de Arriba-Arnau A, Soria V, Menchon JM, Palao DJ, Urretavizcaya M, Cardoner N. Early improvement as a predictor of final remission in major depressive disorder: New insights in electroconvulsive therapy. J Affect Disord. 2018 Aug 1;235:169-175. doi: 10.1016/j.jad.2018.03.014. Epub 2018 Apr 6.

  PMID: 29656263 BACKGROUND

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Officials

• Pascal Sienaert, MD, PhD

  UPC KU Leuven

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Pascal Sienaert, MD,PhD

CONTACT

+322 758 05 11; pascal.sienaert@upckuleuven.be

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants treated with ECT for depression, showing no 'response' (≥50 percent decrease in depressive symptom severity compared to baseline) after 4 treatment sessions will be randomized into 2 treatment groups: either continuation with RUL ECT or switch to BT ECT.

Study Record Dates

• First Submitted: June 1, 2023
• First Posted: June 28, 2023
• Study Start: June 1, 2023
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: July 1, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share

Locations

BE (1)